MAUDE Adverse Event Report: KARL STORZ SE & CO. KG PEDI WORKING ELEMENT

Model Number	27033E
Medical Device Problem Codes	Reflux within Device (1522); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	06/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The karl storz instrumentation being used for the procedure was from a rental set.Our sales representative was present during the procedure, and he noted the resectoscope working element was leaking badly.He discovered the washer (part # 9466590) for use with the working element was still in the rental set case and was most likely not on the working element.A missing washer would have caused the working element to leak.
Event or Problem Description
Allegedly, during an incision of urethra valve procedure, saline was leaking from the resectoscope due to a washer that was missing; the surgeon was unable to maintain distension and removed and reinserted the scope several times to troubleshoot the problem, which resulted in a urethral tear.

• Brand Name: PEDI WORKING ELEMENT
• Common Device Name: WORKING ELEMENT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 8759084
• Report Number: 9610617-2019-00057
• Device Sequence Number: 16516193
• Product Code: HIH
• UDI-Device Identifier: 04048551074893
• UDI-Public: 4048551074893
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K882270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 27033E
• Device Catalogue Number: 27033E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 8 DA